Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

Diabetic Macular Edema Clinical Trial

— OPERA  

Official title:

Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613716
• Other study ID #: 115200
• Status: Completed
• Phase: Phase 4
• Start date: July 2012
• Est. completion date: February 2017

Study information

• Verified date: April 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.

Description:

The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients who are undergoing pars plana vitrectomy for:

• Epiretinal membrane/vitreomacular traction or

• Diabetic macular edema

2. Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness)

3. Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.

4. Age between 18-85 years old

Exclusion Criteria:

1. Age < 18 years or > 85 years

2. History of macular edema due to diseases other than those in the inclusion criteria in the study eye

• History of active inflammatory eye disease (uveitis) (within 3 months)

• History of ocular malignancy and/or ocular/orbital irradiation

• History of recent retinal vein occlusion (within 6 months)

• History of neovascular age-related macular degeneration or choroidal neovascular membrane [

• History of juxtafoveal telangiectasia

• History of Coat's disease

• History central serous choroidoretinopathy

• History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc)

3. Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis)

4. Patients who are cognitively impaired or those who are unable to provide informed written consent

5. Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded).

6. Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks).

7. Patients with recent periocular steroid injection (within past 4 weeks) in the study eye

8. Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Epiretinal Membrane
• Macular Edema

Intervention

Drug:
• Ozurdex
Ozurdex .7 mg injected into the treated eye

Locations

Country	Name	City	State
United States	Cole Eye Institute, Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Retinal Thickness	At 3 months, central retinal thickness as measured by optical coherence tomography will be measured	3 months
Primary	Visual Acuity	ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.	3 months